To: smh who wrote (2756 ) 1/31/2001 9:41:03 PM From: Biomaven Read Replies (1) | Respond to of 52153 Wednesday January 31, 6:45 pm Eastern Time Alexion tumbles on confusion over heart-trial drug data By Ransdell Pierson NEW YORK, Jan 31 (Reuters) - Shares of Alexion Pharmaceuticals Inc. (NasdaqNM:ALXN - news) fell sharply on Wednesday as analysts cited confusion with trial data on the company's experimental anti-inflammatory drug used to treat patients undergoing heart surgery. Shares of the Cheshire, Conn.-based biotech firm closed down $7-11/16 to $52-5/16, or almost 13 percent, on the Nasdaq. That follows declines of $9 on Tuesday and $5-3/4 on Monday -- for a total drop of 30 percent since Jan. 26. Alexion on Jan. 23 issued a statement that indicated clinical trial data showed strong efficacy of its drug, pexelizumab, in reducing death and heart attacks among patients who underwent coronary artery bypass graft surgery (CABG). In the statement, the company described positive preliminary results from the Phase II trial as ``unanticipated'' and Alexion Chief Executive Leonard Bell said the data ``substantially surpassed ... pre-trial expectations.'' Shares of the firm, which is developing pexelizumab in collaboration with the pharmaceuticals unit of consumer products giant Procter & Gamble (NYSE:PG - news), shot up and closed almost 25 percent higher that day. But data highlighted in the Jan. 23 release, as it turns out, referred to secondary trial data involving a subgroup of patients tested, not to data about the primary goal of the trial among all 914 patients tested. At the time, many assumed the statement referred to the primary goals of the trial, analysts said. Alexion issued another statement on the evening of Friday, Jan. 26, saying the drug actually failed in its combined primary goal, or endpoint, of reducing small heart attacks, neurological deficits and damage to the left ventricle, the heart's pumping chamber. ``In the original press release, there was no mention at all of a primary endpoint, not even a passing reference. It made (the trial) sound like an overwhelming success, when it actually missed its primary endpoint,'' said drug analyst Robert Leboyer of Leerink Swann & Co. Another analyst, who asked not to be mentioned by name, said data from the trial were impressive enough that the company now plans a larger Phase III trial of the drug in heart-surgery patients. ``But people don't feel comfortable with the company anymore. There's a lot of disbelief in the data. People would feel more comfortable if Alexion had done an upfront analysis'' in the first statement, the analyst said. Bell, a former Yale professor of medicine, told Reuters in an interview on Wednesday that he and his company had been straightforward with investors and analysts. ``We feel we disclosed everything in a detailed fashion,'' Bell said. Although the primary goal did not appear in the first statement, Bell said Alexion officials gave a detailed explanation of the primary goals of the trial in a conference call with analysts the day the release went out. ``We fully disclosed (the data on the primary goal) in the conference call. I think we made a full disclosure with about an hour-long discussion when we exquisitely went over our data,'' Bell said. Based on favorable results among a subgroup of patients in the heart-surgery trial, Bell said the firm plans to conduct its follow-up Phase III study ``in mid-2001.'' Procter & Gamble spokeswoman Marlene Feder said Alexion's results were ``promising'' and that P&G would continue to assist Alexion develop and test the drug. ``Our scientists will work with them to design their clinical trials going forward,'' Feder said. She declined to comment on Alexion's Jan. 23 statement. (Additional reporting by Jed Seltzer) I sold some more yesterday - but it looks like I should have sold it all (as Miljenko did). I have about 1/3 of my original holding left. Peter